BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BIO-BAG ENVIRONMENTAL CHAMBER (A & B)

    K Number: K791724 · Decision Oct 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    38
    Review Days
    48

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BIO-BAG ENVIRONMENTAL CHAMBER (A & B)
    K Number
    K791724
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Marion Laboratories, Inc.
    Date Received
    August 30, 1979
    Decision Date
    October 17, 1979
    Product Code
    JTX
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JTX Transport Systems, Anaerobic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JTX), ordered by most recent decision date.

    ANAEROBIC ACCU-CULSHURE(TM)

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ACUSON V328 AND C5432 TRANSDUCERS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ACCU-CULSHURE TM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    STANDARDIZE TGCL & TGCH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ANASWAB

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by Marion Laboratories, Inc.

    K Number Device Name
    K883391 POLYMER ADHESIVE BANDAGE
    K875182 MODIFIED LABELING FOR TOXI-LAB THC SCREEN
    K875181 MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM
    K874554 ENVICLUSIVE (TM)
    K874551 ENVINET(TM)
    K874552 ENVISAN PAD
    K874553 ENVISAN PASTE
    K870864 CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST
    K863485 MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST
    K862123 BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE
    Search all 38 clearances from Marion Laboratories, Inc. →